直肠癌的术前放化疗通常与严重的胃肠道（GI）毒性有关，可能会中断、延迟和/或导致治疗终止。在这项研究中，我们评估了 YIV-906（一种被证明可以减少化疗相关胃肠道毒性的新型草药）的添加是否也可以减少新辅助治疗中标准术前卡培他滨和盆腔放射治疗 (RT) 期间的胃肠道副作用。这项单组临床研究于2014年12月23日至2018年9月17日期间在耶鲁纽黑文医院综合癌症中心Smilow癌症医院入组了24名患者。所有患者年龄≥18岁，东部肿瘤合作组0-1组，组织学证实为T3-T4和N0-N2、M0直肠腺癌。中位随访时间为 61.9 个月。所有患者同时接受盆腔外照射放疗（50.4 Gy，28 次）、YIV-906（每周放疗第 1-4 天口服 800 mg，每天两次），并以新辅助方式口服卡培他滨，然后接受确定性手术。在放射期间每周评估毒性，直到急性症状解决，然后在第 28 天、4 个月、7 个月和 10 个月评估毒性。毒性按照不良事件通用术语标准 (CTCAE) 4.0 版进行分级。手术时，4 名患者 (16.7%) 出现完全或接近完全缓解。中位随访时间为 61.9 个月，我们患者队列的平均总生存期 (OS) 为 74.9 个月 [95% 置信区间 (CI)：67.3-82.5]。估计 5 年 OS 为 82.0%。我们观察到 0% 的急性 4 级毒性，仅两例急性 3 级腹泻 (8.3%)。与历史对照相比，在基于卡培他滨的放化疗中添加 YIV-906 导致胃肠道毒性发生率降低。特别是 3 级或以上腹泻。这些发现表明，YIV-906 应该在随机临床试验中进行评估，以进一步评估放化疗对胃肠道癌症毒性特征的潜在降低。2024 年胃肠肿瘤学杂志。版权所有。

Pre-operative chemoradiation for rectal cancer is often associated with severe gastrointestinal (GI) toxicity which can interrupt, delay, and/or lead to termination of treatment. In this study, we evaluated whether the addition of YIV-906, a novel herbal medicine proven to reduce GI toxicity associated with chemotherapy could also reduce GI side effects during standard pre-operative capecitabine and pelvic radiation therapy (RT) in the neoadjuvant setting for the treatment of locally advanced rectal cancer.This single arm clinical study enrolled 24 patients between Dec 23, 2014-Sep 17, 2018 at Smilow Cancer Hospital, a comprehensive cancer center at Yale New Haven Hospital. All patients were age ≥18 years, Eastern Cooperative Oncology Group 0-1 and with histologically confirmed T3-T4 and N0-N2, M0 adenocarcinoma of the rectum. Median follow-up was 61.9 months. All patients received concurrent pelvic external beam RT (50.4 Gy in 28 fractions), YIV-906 (taken orally 800 mg twice daily on days 1-4 of RT each week), and oral capecitabine delivered in a neo-adjuvant fashion, followed by definitive surgery. Toxicity was assessed weekly during radiation and until acute symptoms resolved and then at 28 days, 4 months, 7 months and 10 months. Toxicities were graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.At the time of surgery, 4 patients (16.7%) had a complete or near-complete response. At a median follow-up of 61.9 months, the mean overall survival (OS) of our patient cohort was 74.9 months [95% confidence interval (CI): 67.3-82.5]. The estimated 5-year OS was 82.0%. We observed 0% acute grade 4 toxicities, and only two cases of acute grade 3 diarrhea (8.3%).The addition of YIV-906 to capecitabine based chemoradiation for locally advanced rectal cancer led to reduced rates of GI toxicity compared to historical controls, in particular grade 3 or greater diarrhea. These findings suggest YIV-906 should be evaluated in a randomized clinical trial to further assess potential reductions in the toxicity profile of chemoradiation for GI cancers.2024 Journal of Gastrointestinal Oncology. All rights reserved.